NCT06027684

Brief Summary

The goal of this study is to investigate how the experiences of intensive care patients and their end-of-life wishes affect their willingness to accept intensive care treatment at different chances of survival. The main questions it aims to answer are:

  • What can ICU survivors' experiences of ICU treatment tell us about what it would be like to die whilst receiving ICU treatment?
  • How do ICU survivors' reflections about what it might be like to die on ICU relate to their own preferences for their end-of-life care?
  • What chance of survival would make ICU survivors willing to go through ICU treatment again, in light of the fact that the alternative chance is dying whilst experiencing ICU treatment?
  • How does the possibility of reduction in health-related quality of life and functional decline as a result of critical illness impact ICU survivors' willingness to accept ICU treatment again? Participating in this study will involve filling out a questionnaire and then taking part in an interview. Participants will be recruited through ICU review clinics and ICU steps groups. The study will last for two years and will be conducted at locations convenient to the participants or via zoom.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

August 9, 2023

Last Update Submit

January 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The chance of survival that would make participants willing to go through critical care treatment again.

    The mixed methods approach will involve triangulation of qualitative and questionnaire data about participants' experiences of intensive care treatment, end-of-life wishes, and the chance of survival that would make them willing to go through critical care treatment again.

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult (over the age of 18) participants who have experience as a patient on an intensive care/critical care unit will be recruited in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, M13 9PL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas M Donaldson, MB/BChir

    University of Manchester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

August 9, 2023

First Posted

September 7, 2023

Study Start

October 2, 2023

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

At the end of the project, the investigators will deposit a fully anonymised dataset \[e.g., including de-identified interview transcripts\] in an open data repository where it will be permanently stored. The investigators will use Figshare at the University of Manchester Library. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check the analysis and results. Participants are informed of this in the participant information sheet and will be asked to consent to this on the consent form.

Time Frame
At the end of the study.

Locations